Država: Velika Britanija
Jezik: engleski
Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)
Methylphenidate hydrochloride
Medice UK Ltd
N06BA04
Methylphenidate hydrochloride
10mg
Modified-release capsule
Oral
Schedule 2 (CD)
Caution - AMP level prescribing advised
BNF: 04040000; GTIN: 4250142103046 5060106551085
This info is to help you learn the main things about your medicine called Medikinet ® XL. If you don’t enjoy reading, someone like your mum, dad or carer (sometimes called ‘your guardian’) can read it to you and answer any questions. It may help if you read small bits at a time. WHY HAVE I BEEN GIVEN THIS MEDICINE? This medicine can help children and young people with ‘ADHD’. • ADHD can make you: - run about too much - not be able to pay attention - act quickly without thinking about what will happen next (impulsive). • It affects learning, making friends and how you think about yourself. It is not your fault. WHILE YOU ARE TAKING THIS MEDICINE • as well as taking this medicine you will also get help with ways to you cope with your ADHD such as talking to ADHD specialists. • this medicine should help you. But it does not cure ADHD. • you will need to go to your doctor several times a year for check ups. This is to make sure the medicine is working and that you are growing and developing OK. • if you take the medicine for more than one year, your doctor may stop your medicine to see if it is still needed. This will probably happen in a school holiday. • if you take this medicine more than once a day, you may have to remember to take it AT SCHOOL OR COLLEGE. You or your mum, dad or carer will need to find out what the school rules are about this. • do not drink alcohol. Alcohol may make the side effects of this medicine worse. • If you are having sex, please talk to your doctor about contraception. Girls must tell their doctor straight away if they think they may be pregnant. We do not know how this medicine affects unborn babies. SOME PEOPLE CANNOT HAVE THIS MEDICINE You cannot have this medicine if: • you have a problem with your heart • you feel very unhappy, depressed or have a mental illness. SOME PEOPLE NEED TO TALK TO THEIR DOCTOR BEFORE THEY START HAVING THIS MEDICINE You need to talk to your doctor if: • you have epilepsy (fits) • you are pregnant or breastfeeding • y Pročitajte cijeli dokument
OBJECT 1 MEDIKINET XL 10 MG MODIFIED-RELEASE CAPSULES, HARD Summary of Product Characteristics Updated 09-Feb-2018 | Flynn Pharma Ltd 1. Name of the medicinal product MEDIKINET XL 5 MG modified-release capsules, hard MEDIKINET XL 10 MG modified-release capsules, hard MEDIKINET XL 20 MG modified-release capsules, hard MEDIKINET XL 30 MG modified-release capsules, hard MEDIKINET XL 40 MG modified-release capsules, hard MEDIKINET XL 50 MG modified-release capsules, hard MEDIKINET XL 60 MG modified-release capsules, hard 2. Qualitative and quantitative composition MEDIKINET XL 5 MG modified-release capsules, hard Each modified-release capsule, hard contains 5 mg methylphenidate hydrochloride, equivalent to 4.35 mg methylphenidate. Excipient with known effect: 63.57 mg – 72.71 mg sucrose/modified-release capsule, hard MEDIKINET XL 10 MG modified-release capsules, hard Each modified-release capsule, hard contains 10 mg methylphenidate hydrochloride, equivalent to 8.65 mg methylphenidate. Excipient with known effect: 127.14 mg – 145.42 mg sucrose/modified-release capsule, hard MEDIKINET XL 20 MG modified-release capsules, hard Each modified-release capsule, hard contains 20 mg methylphenidate hydrochloride, equivalent to 17.30 mg methylphenidate. Excipient with known effect: 114.65 mg – 131.13 mg sucrose/modified-release capsule, hard MEDIKINET XL 30 MG modified-release capsules, hard Each modified-release capsule, hard contains 30 mg methylphenidate hydrochloride, equivalent to 25.95 mg methylphenidate. Excipient with known effect: 69.60 mg – 79.61 mg sucrose/modified-release capsule, hard MEDIKINET XL 40 MG modified-release capsules, hard Each modified-release capsule, hard contains 40 mg methylphenidate hydrochloride, equivalent to 34.60 mg methylphenidate. Excipient with known effect: 92.80 mg – 106.14 mg sucrose/modified-release capsule, hard MEDIKINET XL 50 MG modified-release capsules, hard Each modified-release capsule, hard contains 50 mg methylphenidate hydrochloride, equivalent to 43.25 mg methylphe Pročitajte cijeli dokument